Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab

PHASE2RecruitingINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

October 28, 2021

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
HER2-positive Breast Cancer
Interventions
BIOLOGICAL

HER-2 pulsed DC1

Vaccine will be administered weekly for 6 weeks. Boosters will be given at months 6, 9 and 12.

DRUG

Trastuzumab

8mg/kg IV Trastuzumab will be given week 1, followed by 6 mg/kg on subsequent cycles every 3 weeks

DRUG

Pertuzumab

840 mg IV Pertuzumab will be given week 1, followed by 420 mg on subsequent cycles every 3 weeks.

DRUG

Paclitaxel

80 mg/m\^2 IV paclitaxel will be given weekly weeks 7-18

PROCEDURE

Resection surgery

After week 18, participants will undergo standard of care resection surgery.

Trial Locations (1)

33612

RECRUITING

Moffitt Cancer Center, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ImmunoRestoration

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER